Intraocular PressureNCT02985567
An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
An observational study of Intraocular Pressure and Anesthesia, run by Johns Hopkins University at 1 site in Saudi Arabia.
Trial summary
The study involves a prospective evaluation of chloral hydrate sedation for the measurement of intraocular pressure in children ages one month to five years of age. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Intraocular Pressure, Anesthesia
- What is being tested?
- Intraocular pressure evaluation
- How many people
- 324 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1 month to five years requiring sedation for ophthalmic care at King Khaled Eye Specialist Hospital (KKESH).
Who may be able to join
- ages 1 month to five years
- require sedation for ophthalmic care
Who cannot join
- weight <3 kg or >20 kg
- infection/ocular surface disease
- medical contraindication of chloral hydrate
- green or gray nasal discharge
- fever, productive cough, chest retractions, or other signs of respiratory infection
- oxygen saturation < 90%
Show all 11Show fewer
- active infectious disease such as rubella or varicella
- rectal or tympanic temperature > 37.7 degrees, or oral or temporal artery temperature > 37.2 degrees
- history of current ongoing vomiting and diarrhea
- anemia (Hgb < 9.0mg),
- history of seizure in past 6 weeks
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Khaled Eye Specialist Hospital (KKESH)
Riyadh, Riyadh Region, 12329
About this study
The study involves a prospective evaluation of chloral hydrate sedation for the measurement of intraocular pressure in children ages one month to five years of age.
Read the detailed description
This study will be a prospective, non-randomized trial of children 1 month to 5 years of age who are determined to require a sedation procedure at the King Khaled Eye Specialist Hospital (KKESH). There will be two parts to the consent process. Oral consent will be administered to subjects who are not undergoing eye pressure evaluation. These children have chloral hydrate sedation for imaging or other eye evaluations. For these children, we will prospectively monitor the success rate of chloral hydrate sedation such that a complete ophthalmic or imaging evaluation could be performed and will determine the proportion of adverse events that occur due to sedation including vomiting, respiratory distress or depression, alterations in vital signs beyond reference ranges for normal sleeping children, hypoxia with oxygen saturation <90%, and unplanned hospital admission. No testing will be performed for study purposes on these individuals.
For children undergoing sedation who will have intraocular pressure measurements for clinical care purposes, we will perform additional eye pressure measurements as part of the research protocol. Written consent will be obtained to allow us to additionally measure their intraocular pressure as specified below.
After recruitment and completion of informed consent procedures by parents, subjects' medical and ocular history will be reviewed by a study ophthalmologist and one of two pediatricians overseeing sedation procedures. Patients unable to undergo intraocular pressure measurement due to infection or ocular surface disease and those in whom chloral hydrate sedation is medically contraindicated will be excluded. Age, gender, diagnosis, current medications and surgical history will be recorded from the clinical chart for all subjects.
- Conditions
- Intraocular Pressure, Anesthesia
- Being tested
- Intraocular pressure evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure evaluationOther
Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.
| Study group | Role | What they receive |
|---|---|---|
| Intraocular pressure evaluation | Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete Receives: Other: Intraocular pressure evaluation | |
| Safety of sedation | Documentation of: 1. The need for repeat dosing of chloral hydrate. 2. The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge 3. Interventions required for the patient including administration of oxygen, and need for intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraocular pressure during chloral hydrate sedation
Unit- mmHg
Measured: 25 minutes after sedation to 125 minutes after sedation
Secondary outcomes (6)
Chloral hydrate dose required for successful sedation
Unit- mg
Measured: Adminstration to adequate sedation (up to 30 minutes)
Time to recovery
Unit- minutes
Measured: Sedation induction to 125 minutes after sedation
Hear rate under sedation
Unit- beats per minute
Measured: Sedation induction to 125 minutes after sedation
Blood pressure under sedation
Unit- mmHg
Measured: Sedation induction to 125 minutes after sedation
Oxygen saturation under sedation
Unit- %
Measured: Sedation induction to 125 minutes after sedation
Adverse events related to chloral hydrate sedation
Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest
Measured: Sedation induction to 125 minutes after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- King Khaled Eye Specialist Hospital
- Responsible party
- Principal investigator, David S. Friedman, Johns Hopkins University
- Investigators
- David S Friedman, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985567
- Sponsor's protocol ID
- 00086598
- Status last verified
- Dec 2016
- First submitted
- 30 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vade A, Sukhani R, Dolenga M, Habisohn-Schuck C. Chloral hydrate sedation of children undergoing CT and MR imaging: safety as judged by American Academy of Pediatrics guidelines. AJR Am J Roentgenol. 1995 Oct;165(4):905-9. doi: 10.2214/ajr.165.4.7676990.
PubMed 7676990Litman RS, Soin K, Salam A. Chloral hydrate sedation in term and preterm infants: an analysis of efficacy and complications. Anesth Analg. 2010 Mar 1;110(3):739-46. doi: 10.1213/ANE.0b013e3181ca12a8. Epub 2009 Dec 23.
PubMed 20032023
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
- ClinicalTrials.gov ID
- NCT02985567
- Acronym / sponsor ID
- 00086598
- Conditions
- Intraocular Pressure, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- King Khaled Eye Specialist Hospital
- Study start
- Sep 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study involves a prospective evaluation of chloral hydrate sedation for the measurement of intraocular pressure in children ages one month to five years of age.
Detailed description
This study will be a prospective, non-randomized trial of children 1 month to 5 years of age who are determined to require a sedation procedure at the King Khaled Eye Specialist Hospital (KKESH). There will be two parts to the consent process. Oral consent will be administered to subjects who are not undergoing eye pressure evaluation. These children have chloral hydrate sedation for imaging or other eye evaluations. For these children, we will prospectively monitor the success rate of chloral hydrate sedation such that a complete ophthalmic or imaging evaluation could be performed and will determine the proportion of adverse events that occur due to sedation including vomiting, respiratory distress or depression, alterations in vital signs beyond reference ranges for normal sleeping children, hypoxia with oxygen saturation <90%, and unplanned hospital admission. No testing will be performed for study purposes on these individuals.
For children undergoing sedation who will have intraocular pressure measurements for clinical care purposes, we will perform additional eye pressure measurements as part of the research protocol. Written consent will be obtained to allow us to additionally measure their intraocular pressure as specified below.
After recruitment and completion of informed consent procedures by parents, subjects' medical and ocular history will be reviewed by a study ophthalmologist and one of two pediatricians overseeing sedation procedures. Patients unable to undergo intraocular pressure measurement due to infection or ocular surface disease and those in whom chloral hydrate sedation is medically contraindicated will be excluded. Age, gender, diagnosis, current medications and surgical history will be recorded from the clinical chart for all subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraocular pressure evaluation | – | Other: Intraocular pressure evaluationIntraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete |
| Safety of sedation | – | –Documentation of: 1. The need for repeat dosing of chloral hydrate. 2. The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge 3. Interventions required for the patient including administration of oxygen, and need for intubation. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 month to five years requiring sedation for ophthalmic care at King Khaled Eye Specialist Hospital (KKESH).
Key inclusion criteria (2 listed)
- ages 1 month to five years
- require sedation for ophthalmic care
Key exclusion criteria (11 listed)
- weight <3 kg or >20 kg
- infection/ocular surface disease
- medical contraindication of chloral hydrate
- green or gray nasal discharge
- fever, productive cough, chest retractions, or other signs of respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressure evaluationIntraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete. | Other | Intraocular pressure evaluation |
Primary outcome
Change in intraocular pressure during chloral hydrate sedation
Time frame: 25 minutes after sedation to 125 minutes after sedation
Unit- mmHg
6 secondary outcomes
Chloral hydrate dose required for successful sedation
Time frame: Adminstration to adequate sedation (up to 30 minutes)
Time to recovery
Time frame: Sedation induction to 125 minutes after sedation
Hear rate under sedation
Time frame: Sedation induction to 125 minutes after sedation
Blood pressure under sedation
Time frame: Sedation induction to 125 minutes after sedation
Oxygen saturation under sedation
Time frame: Sedation induction to 125 minutes after sedation
Adverse events related to chloral hydrate sedation
Time frame: Sedation induction to 125 minutes after sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 7676990Vade A, Sukhani R, Dolenga M, Habisohn-Schuck C. Chloral hydrate sedation of children undergoing CT and MR imaging: safety as judged by American Academy of Pediatrics guidelines. AJR Am J Roentgenol. 1995 Oct;165(4):905-9. doi: 10.2214/ajr.165.4.7676990.
- Background: PubMed 20032023Litman RS, Soin K, Salam A. Chloral hydrate sedation in term and preterm infants: an analysis of efficacy and complications. Anesth Analg. 2010 Mar 1;110(3):739-46. doi: 10.1213/ANE.0b013e3181ca12a8. Epub 2009 Dec 23.
- Individual participant dataSharing planned: No
Related trials for Intraocular Pressure
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Friedman, MD, MPH, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Anesthesia, run by Johns Hopkins University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraocular pressure during chloral hydrate sedation (time frame: 25 minutes after sedation to 125 minutes after sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.